Medical device recalls
Device recalls are the largest single group in this archive, because the FDA logs corrections and removals as well as outright withdrawals. Many are handled entirely between the manufacturer and a hospital and need nothing from a patient. Each notice states who has to act.
13,634 stored notices, reported between Jun 20, 2012 and Sep 9, 2026. Newest first.
Reported Aug 21, 2024
VITROS Immunodiagnostic VITROS Folate Reagent Pack 1/2
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ortho-Clinical Diagnostics, Inc.
FDA (openFDA device enforcement)
Reported Aug 21, 2024
Orthopantomograph OP300 dental computed tomography x-ray system. The X-ray device produces conventional 2D X-ray images…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Palodex Group Oy
FDA (openFDA device enforcement)
Reported Aug 21, 2024
HeartMate 3 System Controllers provided within the following HeartMate 3 Left Ventricular Assist System (LVAS) Implant…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Thoratec LLC
FDA (openFDA device enforcement)
Reported Aug 14, 2024
American Contract Systems Hand Pack convenience kit
Moderate riskThis product could cause temporary or reversible health problems — stop using it.American Contract Systems, Inc.
7 more products in this recall
FDA (openFDA device enforcement)
Reported Aug 14, 2024
CryoValve SG Pulmonary Human Heart Valve, SGPV00, Cryopreserved Decellularized Heart Valve Allograft Prepared with…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Artivion, Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Aug 14, 2024
Baxter PST 500 U, Precision Surgical Table, Part number (product code) 4080300
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Baxter Healthcare Corporation
1 more product in this recall
FDA (openFDA device enforcement)
Reported Aug 14, 2024
BIOFIRE FILMARRAY Gastrointestinal (GI) Panel REF RFIT-ASY-0116 (30 test kit) BIOFIRE FILMARRAY Gastrointestinal (GI)…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.BioFire Diagnostics, LLC
FDA (openFDA device enforcement)
Reported Aug 14, 2024
BD PYXIS MEDBANK MINI CR-2HH-1FH-P, REF: 169-114 containing software version 3.9.1.9
Moderate riskThis product could cause temporary or reversible health problems — stop using it.CareFusion 303, Inc.
18 more products in this recall
FDA (openFDA device enforcement)
Reported Aug 14, 2024
Puritan Bennett 500 Series Ventilators (Description/REF): PURITAN BENNETT 560 VENTILATOR/4096600, PURITAN BENNETT PB560…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Covidien
FDA (openFDA device enforcement)
Reported Aug 14, 2024
SIGNA Architect, with affected software versions: DV26.0 to DV26.3, DV27.0 to DV27.3, DV28.0 to DV28.5, DV29.0, DV29.1,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Medical Systems, LLC
25 more products in this recall
FDA (openFDA device enforcement)
Reported Aug 14, 2024
TruDi NAV Suction, 0 Degrees; Model/Catalog Number: TDNS000Z. TruDi" NAV Suction Instruments are intended for use with…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Integra LifeSciences Corp.
FDA (openFDA device enforcement)
Reported Aug 14, 2024
Leica HistoCore Arcadia H, REF: 14039354100 and 14039357258, Paraffin Embedding Station.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Leica Biosystems Nussloch GmbH
FDA (openFDA device enforcement)
Reported Aug 14, 2024
NavaClick Syringe and Needle, Model Number LIN02
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Lineage Biomedical, Inc.
FDA (openFDA device enforcement)
Reported Aug 14, 2024
Verigene Gram Positive Blood Culture (BC-GP) Nucleic Acid Test
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Luminex Corporation
FDA (openFDA device enforcement)
Reported Aug 14, 2024
Medline procedure kits labeled as: 1) CONTINUOUS BLOCK, Pack Number DYNJRA0960C; 2) COMBINED SPINAL AND EPIDURAL, Pack…
High riskUsing this product could cause serious injury, illness or death — stop using it now.MEDLINE INDUSTRIES, LP - Northfield
4 more products in this recall
FDA (openFDA device enforcement)
Reported Aug 14, 2024
Soltive Premium SuperPulsed Laser System, Model TFL-PLS
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Olympus Corporation of the Americas
5 more products in this recall
FDA (openFDA device enforcement)
Reported Aug 14, 2024
Philips Azurion Interventional Fluoroscopic X-ray System with Software Version Number: R1.0, R1.1, R1.2- Intended for…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips Medical Systems Nederland B.v.
FDA (openFDA device enforcement)
Reported Aug 14, 2024
IntelliVue Patient Monitor MX400 with L.x and M.x; K.x provided with L.x entitlements Model Number: 866060. Indicated…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips North America LLC
3 more products in this recall
FDA (openFDA device enforcement)
Reported Aug 14, 2024
Luminos Agile Max -Intended to visualize anatomical structures by converting an x-ray pattern into a visible image.…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Siemens Medical Solutions USA, Inc.
3 more products in this recall
FDA (openFDA device enforcement)
Reported Aug 14, 2024
CADD-Solis Ambulatory Infusion Pumps, Model 2100. Intended for the following uses: Indicated for the following uses:…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Smiths Medical ASD Inc.
2 more products in this recall
FDA (openFDA device enforcement)
Reported Aug 14, 2024
Hookup Model/Catalog Number: 2-8-540 Product Description: Hookups provide the interface between an Advantage Plus"…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Steris Corporation
3 more products in this recall
FDA (openFDA device enforcement)
Reported Aug 14, 2024
GORE SEAMGUARD Bioabsorbable Staple Line Reinforcement Configured for Circular Staplers, 25mm; Catalog number: 1BSGC25;
Moderate riskThis product could cause temporary or reversible health problems — stop using it.W.L. Gore & Associates, Inc.
FDA (openFDA device enforcement)
Reported Aug 7, 2024
SOFT-VU KUMPE 5F X 40CM -Used for patients in need of angiographic diagnosis. Catalog Number: 10732702
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Angiodynamics, Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Aug 7, 2024
DxC 500 AU Clinical Chemistry Analyzer, REF C63520 is an automated chemistry analyzer that measures analytes in…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Beckman Coulter Mishima K.K.
FDA (openFDA device enforcement)
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RecallNow is not a government agency. Every notice above was published by the FDA, USDA FSIS or CPSC and links back to its source. Browse the whole archive.